1. Field of the Invention
The present invention relates generally to a method for treatment of skin lesions and internal wounds such as viable but underperfused myocardium. More specifically, this invention is related to a method for treatment of a subject afflicted with inadequate blood perfusion, tissue loss, partial denervation, wounds, bone fractures, burns and/or ulcers, by administration of time varying electromagnetic fields alone or simultaneously with static magnetic fields to the subject of specific characteristics.
2. Description of the Background
Locally applied electromagnetic fields (EMFs) have been shown to increase skin and nerve regeneration, collagen maturation and tensile strength during healing of skin wounds in a rat. In vitro, EMFs have been shown also to induce the proliferation and collagen-mediated production of fibroblasts and foster angiogenesis. In addition, locally applied EMFs have long been known to promote soft tissue repair. Chronic venous leg ulcers and pressure ulcers have been treated by application of various therapies, including the local application of growth factors, hyperbaric oxygen, local infrared irradiation, EMFs, ultra violet and low energy lasers as well as ultrasound, directly to the ulcerated site. The Agency for Health Care Policy and Research of the U.S. Department of Health and Human Services, however, recommended locally applied EMFs as the sole adjunctive therapy with sufficient supporting evidence for the treatment of pressure ulcers. Although the local application of EMFs has been used to treat chronic venous leg ulcers, nerve regeneration, bone nonunionis and to protect animal models from the sequela of provoked ischemia, all attempts to attain healing by administration of EMFs at a point distant from the afflicted site have failed up to the present time.
The ability of treating wounds and other ailments without administering the EMFs at the wound site while attaining an improvement, and even full healing of the wound, would be of great help, particularly in cases where the wound site is somewhat inaccessible or simply to avoid inconveniencing the patient. Such treatment could be administered on an out-patient basis, would not require highly skilled personnel and would reduce the cost of treatment while freeing medically trained personnel for the diagnosis and prescription of therapies and for following up the results attained in any particular round of applications.
Accordingly, there is a clear need for an improved method for accelerating and fostering of healing of a subject""s wounds, particularly those wounds that prove to be resistant to other more conventional treatments, which is simple, does not inconvenience the subject, may be performed on an out-patient""s basis by non-highly skilled personnel, and that does not inconvenience the patient. Such treatment would be highly therapeutic and cost effective.
This invention relates to a method of treating lesions, burns, skin ulcers, and viable but underperfused myocardium, which comprises applying externally and non-invasive extremely low frequency electromagnetic fields (EMFs) of specific characteristics to a subject afflicted with a lesion burn and ulcer, at a site removed from the site of the lesion under conditions effective to accelerate lesion, burn, bone or ulcer healing, to enhance angiogenesis and vasculogenesis and to improve the effect of other subsequently applied therapies. Suitable EMFs comprise a time-varying electromagnetic field component generated at frequencies of a few Hertz (more than one) to less than about 300 Hz and static magnetic field components having an intensity of about few micro Tesla, e.g., about 2-5 xcexcT, about 20 xcexcT to about 100 xcexcT, about 0.3 mT, about 0.8 mT. These EMFs may be used alone or in combination with a homogeneous static magnetic field of about 40, about 50 to about 70, about 80 mT (or about 400, about 500 to about 700, about 800 Gauss). Although in some cases, the measured frequencies inside the coils are about 0.3 to about 0.8 xcexcT, in those areas of the skin close but not inside the coils, the intensities of the EMF are progressively reduced down to the environmental magnetic fields.
The method of this invention is particularly suited for the therapeutic treatment of subjects afflicted with skin lesions such as burns, internal wounds such as bone fractures, partial denervation, and ulcers, particularly chronic wounds, such as venous and arterial leg ulcers, pressure ulcers, unhealing wounds, infected wounds, painful inflamed tissue, areas of inadequate blood perfusion, such as viable but underperfused myocardium and the like, which are present either by themselves or in association with other causes, e.g. atherosclerosis, varicose veins, diabetes, hypertension, rheumatoid arthritis, trauma, and the like. Some lesions are resistant or non-responsive to treatment with surgical or conservative conventional methods, but the administration of the present therapy makes them highly responsive to previously ineffective treatments. The present method may be administered for a short period of time as well as through periodically exposing an already treated subject to repeated treatments over a period of time effective for reducing the intensity of pain, edema, inflammation and infection, increasing angiogenesis, vasculogenesis, nerve regeneration, bone union and reestablishing the subject""s own immune-mediated anti-inflammatory response and wound healing processes.
The present therapeutic method greatly reduces the healing time in subjects who had proved previously highly resistant to other conventional medical treatments.
The present invention will be further illustrated by reference to the various drawings and the several examples hereinafter described.